Abbott CentriMag Reference Manual
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Abbott CentriMag Reference Manual

Circulatory support system
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CentriMag
READ ALL INDIVIDUAL CENTRIMAG SYSTEM COMPONENT INSTRUCTIONS FOR USE (IFU), THE CENTRIMAG CIRCULATORY
SUPPORT SYSTEM OPERATION MANUAL, AND THE ENTIRE CONTENTS OF THIS MANUAL BEFORE USING THE CENTRIMAG
Abbott Medical Clinical & Technical Support Phone number(s)
United States
Manufacturer:
Thoratec Switzerland GmbH
Technoparkstrasse 1
CH-8005 Zürich
Switzerland
™
Circulatory Support System
Clinical Reference Manual
CIRCULATORY SUPPORT SYSTEM.
Emergency HeartLine™
Support USA:
Abbott Medical Main
Switchboard:
Tel: +1-800-456-1477
Tel: +1-925-847-8600
Fax: +1-925-847-8574
US Headquarters:
Abbott Medical
6035 Stoneridge Drive
Pleasanton, CA 94588
USA
www.abbott.com
PL-0318, Rev. 00
DCO No. 19-038
December 2019

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Summary of Contents for Abbott CentriMag

  • Page 1 Clinical Reference Manual READ ALL INDIVIDUAL CENTRIMAG SYSTEM COMPONENT INSTRUCTIONS FOR USE (IFU), THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM OPERATION MANUAL, AND THE ENTIRE CONTENTS OF THIS MANUAL BEFORE USING THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM. Abbott Medical Clinical & Technical Support Phone number(s) Emergency HeartLine™...
  • Page 2 ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner. Pat. http://www.abbott.com/patents © 2019 Abbott. All Rights Reserved.

  • Page 3: Table Of Contents

    Potential Adverse Events ............................6 Warnings and Cautions ............................6 Terminology and Abbreviations ..........................7 Description ..............................7 Clinical Use of the CentriMag Circulatory Support System ..................8 General Principles ................................8 Types of Support ................................9 Preparing for CentriMag System Use ........................9 System Setup..................................
  • Page 4 Safety and Effectiveness and Results ..........................27 Device Malfunctions and Failures ............................ 30 Clinical Study Safety and Effectiveness Conclusions ......................33...

  • Page 5: Introduction

    Adverse events (e.g., complications) are a known risk of mechanical circulatory support use. The adverse events observed during four clinical studies of the CentriMag system are listed below. The adverse events are listed in decreasing order of frequency, except for death, because it is a non-reversible complication.

  • Page 6: Terminology And Abbreviations

     Description The CentriMag system is designed to provide a versatile and effective means for implementing mechanical circulatory support in a variety of clinical scenarios. The system is intended to treat acute heart failure by decreasing ventricular workload, stabilizing hemodynamic conditions, and facilitating potential myocardial recovery. Patients in acute cardiac failure are at risk of developing multisystem organ failure which can threaten long-term survival.

  • Page 7: Clinical Use Of The Centrimag Circulatory Support System

    Configurable as an LVAD, RVAD, or BiVAD  The CentriMag pump is a continuous flow, fully magnetically levitated centrifugal pump. When the pump is inserted into the motor and activated, the internal impeller is electromagnetically levitated and centered. Large gaps between the impeller and pump housing are designed to minimize potential shear forces on blood cells, allowing a high blood flow rate with minimal hemolysis and thrombosis.

  • Page 8: Types Of Support

    WARNING: The safety and effectiveness of use of the CentriMag system in an ECMO circuit (i.e. cardiopulmonary support > 6 hours) has not been demonstrated. WARNING: The safety and effectiveness of use of the CentriMag system for use > 30 days has not been demonstrated.

  • Page 9: Submersion Priming Technique

    CentriMag pumps   Drainage cannulas  Return cannulas Generation CentriMag console with motor and flow probe connected  Standard 3/8”ID x 3/32” wall tubing  Two 3/8” straight barbed connectors per pump, if not included with the cannula kits ...
  • Page 10 Repeat for the return tubing segment. CAUTION: The CentriMag pump may magnetically attract to a metal basin. Use caution if a metal basin is used. Open the pump package. Submerge the pump in the saline, rotating from side to side to ensure complete removal of air.

  • Page 11: Cannulas

    Figure 4. Submersion of pump Cannulas For left and/or right sided support for failure to wean, Abbott Medical recommends the CentriMag Drainage (Venous) Cannula (34Fr) and Return (Arterial) Cannula (24Fr). Other equivalent commercially available venous and arterial cannula may be used at the preference of the clinician.

  • Page 12: Surgical Technique For Implantation

    Overview This section describes the surgical considerations necessary to prepare, implant, and explant the CentriMag system. Standard surgical techniques will be used for implantation of the system. The components of the circuit will be similar for most patients, although the surgical procedures may vary according to the patient’s anatomy, circumstances of support initiation and hospital protocols.

  • Page 13: Cannula Site Selection And Cannulation

    Figure 5. Drainage via the left ventricular apex Figure 6. Drainage via the left atrium The CentriMag Return (Arterial) Cannula and the CentriMag Drainage (Venous) Cannula are not intended for peripheral cannulation.

  • Page 14: Intraoperative Device Management

    WARNING: If a suction event occurs and is not addressed promptly, there is potential for air entrainment. Patient Care and Management Postoperative care with the CentriMag system is similar to other types of mechanical circulatory support. Key principles of care include hemodynamic stabilization, adequate anticoagulation, and prevention of wound infection. The intravascular volume must be carefully assessed and controlled.

  • Page 15: Guidelines To Prevent Air Entrainment During Support

    Guidelines to prevent air entrainment during support include the following: Monitor the volume with TEE and pressures.  Reduce CentriMag flow rate while the chest is open.  Reduce RPM for any indication of inadequate volume, during manipulation of the heart, or prior to moving the patient.

  • Page 16: Hemodynamic Assessment And Support

    Although the CentriMag system may capture the majority of blood flow, some ventricular output may be through the aortic or pulmonic valve. CentriMag system flow may also be elevated due to shunts or incompetent valves.

  • Page 17: Anticoagulation

    Patient Transport In some cases, a patient on CentriMag system support may need to be transported to another location within the hospital or to another medical center. The CentriMag system meets international standards for air and ground transport and is designed for ease of use during transport between medical centers.

  • Page 18: Prevention And Management Of Potential Complications

    Prior to shutting off the power supply and removal of the patient from the transport vehicle, briefly unplug the console’s power  cord to confirm adequate battery charge and console operation. For details on the equipment as well as FAA and other standards for transport, refer to the CentriMag Circulatory Support System Operation Manual. Prevention and Management of Potential Complications Potential complications are similar to those seen with other ventricular assist devices.

  • Page 19: Alarms/Alerts And Troubleshooting

    (pulmonary or aortic) valves. A trial period of CentriMag system weaning over at least three hours may be attempted after the following criteria are met: ...

  • Page 20: Pump Exchange

    Using a sterile field and aseptic technique, a new pump or pump and circuit are primed as described in the Preparing for CentriMag System Use section. Tubing connectors are placed at the patient ends of the tubing. It is always advisable to change the pump as well as the tubing, rather than the pump alone.

  • Page 21: Study Design

    Cardiac resuscitation using pharmacologic agents, and epicardial pacing (if appropriate and possible) has been attempted.  Table 7. Inclusion Criteria – Other Premarket CentriMag System Pilot Studies G030052 G040029 Cardiogenic Shock Trial...
  • Page 22 Cardiac resuscitation using pharmacologic agents, and epicardial pacing (if appropriate and possible) has been attempted. The only inclusion criterion for the post-approval study of the CentriMag RVAS HDE (H070004/S1) was 25 consecutive patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.

  • Page 23: Accountability Of The Ftw Study Cohorts

    30 days after CentriMag system removal  Survival was assessed as a percentage of patients discharged alive from the hospital, and at 30 days and 6 months after CentriMag system removal. Adverse events and complications were recorded throughout the duration of CentriMag system support, through device removal and until the patient was discharged from the hospital.

  • Page 24: Study Population Demographics And Baseline Parameters

    The demographics of the study populations are typical for studies of mechanical circulatory support devices performed in the US. Demographic information for the four study populations is summarized in the table below. Table 10. Demographics -All CentriMag System Clinical Studies Clinical Study...
  • Page 25 Table 11. Baseline Hemodynamic Values – FTW from CPB (G030052/S21) Variable Mean Median Systolic Blood 98.6 23.2 94.0 58.0 153.0 Pressure (mmHg) Diastolic Blood 54.2 12.7 52.5 22.0 79.0 Pressure (mmHg) Pulmonary Artery 37.3 14.0 36.0 13.0 58.0 Systolic (mmHg) Pulmonary Artery 22.9 22.0...
  • Page 26 Safety Results The analysis of safety was based on all 95 patients enrolled in the four clinical studies of the CentriMag system described above, thereby providing a more conservative estimate of the safety profile inclusive of all study (mixed) cohorts, not just FTW subjects. Safety was evaluated on the basis of adverse events and device malfunctions.
  • Page 27 Table 13. Summary of Adverse Events, All CentriMag System Clinical Studies IDE G030052 Pivotal IDE G030052 Pilot IDE G040029 Pilot RVAD HDE PAS All CentriMag System Clinical Patients Cardiogenic Shock (BVAD) RVAD w/ LVAD RVAD w/ HMII LVAD (n=32) (n=26)
  • Page 28 Table 13. Summary of Adverse Events, All CentriMag System Clinical Studies IDE G030052 Pivotal IDE G030052 Pilot IDE G040029 Pilot RVAD HDE PAS All CentriMag System Clinical Patients Cardiogenic Shock (BVAD) RVAD w/ LVAD RVAD w/ HMII LVAD (n=32) (n=26)
  • Page 29 Because data on device malfunctions and failures in the clinical studies were limited due to the size of the studies, post-market safety data for the CentriMag system were also used to evaluate the safety of the device. These data were obtained by analyzing adverse events associated with marketed CentriMag systems which were reported to Abbott Medical between June 1, 2014, and June 30, 2019.
  • Page 30 Labeling updates and a cable redesign were initiated and have been approved for commercial distribution. The CentriMag system was the subject of a field action initiated in August 2019 involving reports of motor and pump issues resulting in system/alarm(s)/faults from electromagnetic interference (EMI).
  • Page 31 0.5 – 28.1 Survival at six months after cessation of support with the CentriMag system was also tracked as a secondary effectiveness endpoint in the pivotal study of the failure to wean from CPB indication for use. At six months after device removal survival was 53%, compared to 69% at 30 days after device removal, showing that recovery from the initial hemodynamic instability that required use of the CentriMag system for circulatory support was sustained over time.
  • Page 32 Pivotal Clinical Study. The totality of the available data demonstrates that the CentriMag system is safe and effective for temporary short-term use for up to 30 days.

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